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ORIGINAL ARTICLE
Year : 2020  |  Volume : 9  |  Issue : 2  |  Page : 82-88

Comparison of the efficacy of epidural nalbuphine versus dexmedetomidine on the characteristics of spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries: A prospective randomised, double-blind, placebo-controlled study


Department of Anaesthesiology and Critical Care Medicine, Sri Venkateswara Institute of Medical Sciences, Tirupati, Andhra Pradesh, India

Date of Submission20-Mar-2019
Date of Decision12-Feb-2020
Date of Acceptance13-Feb-2020
Date of Web Publication4-Aug-2020

Correspondence Address:
Peyyety Janaki Subhadra
Associate Professor, Department of Anesthesiology and Critical Care Medicine, Sri Venkateswara Institute of Medical Sciences, Alipiri Road, Tirupati 517 507, Andhra Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JCSR.JCSR_30_19

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  Abstract 


Background: Using adjuvants to local anaesthetic agents either intrathecally or epidurally is a common practice for achieving longer duration of a denser neuraxial block to provide adequate intraoperative conditions, for the length of the procedure.
Methods: We compared the efficacy of epidural dexmedetomidine or nalbuphine on the characteristics of spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries. Ninety patients were randomly allocated to three groups (n = 30 each). Group D received dexmedetomidine 1.5 μg/kg diluted to 5 mL; Group N received nalbuphine 0.2 mg/kg diluted to 5 mL and Group S received 5 mL of normal saline epidurally 10 min before receiving subarachnoid block (SAB) with 0.5% heavy bupivacaine.
Results: The three groups were comparable demographically and haemodynamically. Significantly shorter time for the onset of sensory and motor block (sec), longer duration of sensory and motor blockade (min), higher sedation scores intraoperatively and postoperatively were observed in GroupD compared to other two groups. VAS scores were lower in Group D for a significantly longer period postoperatively, at 60 min, 120 min and 180 min than in other two groups (P < 0.05).
Conclusions: Both dexmedetomidine and nalbuphine were found to be useful and safe epidural adjuvants when given prior to SAB. Dexmedetomidine was found to be a better choice of epidural adjuvant when compared to nalbuphine in terms of earlier onset and longer duration of both sensory and motor block, longer post-operative analgesia and useful intraoperative sedation.

Keywords: Central neuraxial block, dexmedetomidine, nalbuphine


How to cite this article:
Lakshmi E A, Subhadra PJ. Comparison of the efficacy of epidural nalbuphine versus dexmedetomidine on the characteristics of spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries: A prospective randomised, double-blind, placebo-controlled study. J Clin Sci Res 2020;9:82-8

How to cite this URL:
Lakshmi E A, Subhadra PJ. Comparison of the efficacy of epidural nalbuphine versus dexmedetomidine on the characteristics of spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries: A prospective randomised, double-blind, placebo-controlled study. J Clin Sci Res [serial online] 2020 [cited 2020 Sep 21];9:82-8. Available from: http://www.jcsr.co.in/text.asp?2020/9/2/82/291372




  Introduction Top


Surgical patients require effective intraoperative analgesia as well as post-operative pain relief. Use of neuraxial blocks for lower limb orthopaedic surgeries is a common practice which is a time-tested and preferred technique for both intraoperative anaesthesia and post-operative analgesia. Neuraxial anaesthesia has been associated with decreased morbidity, with a reduction in blood loss[1],[2] and surgical-site infections[3] and a lower rate of admission to critical care services,[4] for lower limb orthopaedic surgeries including joint replacement surgeries compared to general anaesthesia.

Combined central neuraxial block (CNB)[5],[6] technique aims to provide a quick and dense anaesthesia (spinal component) and helps to prolong the duration of anaesthesia during the intraoperative period and extending analgesia into the post-operative period (epidural component). It is safer and more reliable when compared to individual techniques of spinal anaesthesia alone or epidural anaesthesia alone (which has the disadvantages of a patchy or inadequate block or dislodged or non-functional catheters and haematoma formation when anticoagulants were in use in that patient).

The current study was undertaken to determine whether administration of nalbuphine and dexmedetomidine epidurally in CNB would provide prolongation of spinal analgesia without causing significant haemodynamic side effects.


  Material and Methods Top


After obtaining approval from the institutional ethics committee and written informed consent, ninety patients undergoing elective lower limb orthopaedic surgery in a tertiary care university teaching hospital in South India were included in the study.

The sample size was based on previous studies, with 26 minimum patients in each group. We included thirty patients per group to allow for dropouts and protocol violations. They were randomly allocated to three groups of thirty each depending on the epidural drug used by a computer-generated randomisation sequence generated before the start of the study, using sealed opaque envelope technique.

Adult patients who were of American Society of Anesthesiologists physical status Grade 1 and 2[7] undergoing elective total knee replacement (TKR) surgery were included in the study. Patients not willing to participate in the study and patients who did not consent for spinal anaesthesia; patients with a past history of spinal surgeries; those with a history of coagulation and bleeding disorders with local site infections; those with a history of hypersensitivity to study drugs; those with a history of uncontrolled hypertension and diabetes mellitus; those with a history of coronary artery disease; patients with increased serum creatinine and liver enzymes 2–3 times the normal; those with a history of neuropsychiatric disorders and communication problems and hence will not understand visual analogue scale (VAS) measurements; pregnant women and lactating mothers and patients of height <140 cm were excluded from the study.

All patients were kept fasting overnight and had received premedication with oral ranitidine 150 mg the night before and on the morning of surgery. Standardised anaesthetic technique for epidural catheter placement and subarachnoid block (SAB) was followed. Ten minutes before receiving SAB by 3 mL of 0.5% hyperbaric bupivacaine, thirty patients of Group D (dexmedetomidine group) received 1.5 μg/kg dexmedetomidine diluted to 5 mL, thirty patients of Group N (nalbuphine group) received 0.2 μg/kg nalbuphine diluted to 5 mL and thirty patients of Group S (saline group) received 5 mL of normal saline – all the three groups epidurally. Intraoperative monitoring included electrocardiography, heart rate (HR), oxygen saturation by pulse oximetry (SpO2) and non-invasive blood pressure. Observations were obtained at the time of injection of study drug (baseline) and every 5 min till the end of the surgery and every 30 min post-operatively until rescue analgesia. The patients were studied for the onset of sensory block to L1; two-segment regression of sensory block; duration of sensory blockade; onset of motor blockade;[8] duration of motor blockade; haemodynamic parameters; sedation scores intraoperatively and post-operatively every 30 min for 6 h; VAS scores post-operatively every 30 min for 6 h and adverse effects such as nausea, vomiting, pruritus and shivering.

Statistical analysis

All the collected data were double checked to exclude any clerical errors and were entered in Microsoft Excel (Microsoft Corporation, Redmond, USA). The data were first evaluated for normality using the Shapiro–Wilk test. Normally distributed data are presented as mean (± standard deviation). Data that were not normally distributed are expressed as median (range). Comparison of normally distributed independent variables in the three groups was done by repeated measures analysis of variance (ANOVA) and an appropriate post hoc test. Comparison of variables that were not normally distributed was done by Kruskal–Wallis test. Categorical variables were compared in the three groups by Chi-square test. A P < 0.05 was considered statistically significant.


  Results Top


Patients in the three groups were comparable demographically [Table 1]. There was no statistically significant difference in haemodynamic parameters among the three groups in our study with regard to the number of episodes of hypotension, HTN, bradycardia and tachycardia; There was no statistically significant difference among the three groups [Table 2].
Table 1: Comparison of demographic data among the study groups

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Table 2: Comparison of block characteristics among the three groups

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Sensory blockade characteristics are shown in [Table 2]. The mean time (sec) to the onset of sensory block to L1 level was significantly lower in Group D (155.8 ± 67.1) when compared to Group S (227.5 ± 92.6) (P = 0.002), whereas time to the onset of sensory block to L1 (sec) was not significantly different between Group D (155.8 ± 67.1) and Group N (184.5 ± 69.7 s) (P = 0.328), and also between Group N (184.5 ± 69.7) and Group S (227.5 ± 92.6) (P = 0.085). The mean time to regression of block below L1 level was shortest in Group S (170.6 ± 26.4 min) and longest in Group D (319.6 ± 90.1 min) suggesting that sensory block in group S wore off earlier than the other two groups. Further, post hoc analysis showed that the difference in the mean time (min) to regression of block below L1 was significantly different between Groups S and D (170.6 ± 26.4 Vs 319.6 ± 90.1) (P < 0.001), Groups S and N (170.6 ± 26.4 Vs 215.8 ± 52.6) (P = 0.017), and Groups N and D (215.8 ± 52.6 Vs 319.6 ± 90.1) (P < 0.001),

The mean duration of analgesia (min) was shortest in Group S and longest in Group D. Statistically significant difference in mean duration of anaesthesia (min) was observed between Group S and Group N (303.1 ± 51.0 Vs 226 ± 37.2) (P = 0.005); Group S and Group D (226 ± 37.2 Vs 468.5 ± 148.6) (P = 0.001); and Group N and Group D (303.1 ± 51.0 Vs 468.5 ± 148.6), (P = 0.001).

The mean time to the onset of motor block (sec) was significantly prolonged in Group S (334 ± 136.95) compared to Group D (238 ± 114.36) (P < 0.001), Group N (262 ± 107.42) (P = NS). In addition, the difference in the mean time to the onset of motor block was not statistically significant between Groups N and D. The mean duration of motor block (min) was shorter in Group S (196.17 ± 28.24) compared to group N (249.67 ± 47.59) and Group D (384.33 ± 111). Post hoc analysis showed that this difference in both sensory and motor block characteristics was statistically significant between Group S and Group N, between Group S and Group D and also between Group N and Group D.

The mean sedation scores in Group D were observed to be comparatively higher than those of Group N and Group S. This difference was found to be statistically significant at all time intervals intraoperatively (at 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min) [P = 0.01] [Table 3]a and [Table 3]b. Post hoc analysis of Ramsay sedation scores taken at all time intervals showed that there was a statistically significant difference between Groups D and N and S and D. However, on comparison between Groups N and S, there was a statistically significant difference in the sedation scores at 30, 60, 90 and 120 min but not at 150 min and 180 min points.


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Postoperatively, the mean sedation scores in Group D were comparatively higher than those of Group N and Group S, which was found to be statistically significant at 30 min, 60 min, 120 min and 180 min No significant difference in the mean sedation score was observed at 240 min, 300 min and 360 min [Table 4]a and [Table 4]b. Post hoc analysis of sedation score postoperatively showed that mean sedation scores in Group D were slightly higher than that of Group N which was statistically significant at 30 min, 60 min, 120 min and 180 min. Group S had lower sedation scores than dexmedetomidine group, which had statistical significance at 30 min, 60 min, 120 min and 180 min but insignificant at 240 min (P = 0.07), at 5 h (P = 0.520) and at 6 h (P = 0.07). Although the mean sedation scores in saline group were found to be slightly lower than those of Group N, it was not statistically significant [Table 4]a and b].


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The mean VAS scores for pain were observed to be significantly higher in Group S than Group D or Group N at 30 min, 60 min, 120 min, 180 min, 240 min, 5 h and at 6 h postoperatively [Table 5]a and [Table 5]b. Group D had lower VAS scores when compared to the other two groups. VAS scores were found to be increased over time [Table 5]a and b]. The mean VAS scores in Group S were found to be significantly higher than those of Group D group, at 60 min, 120 min, 180 min, 240 min, 5 h and at 6 h postoperatively. In addition, VAS scores in Group D were comparatively lower than those of Group N, at 120 min, 180 min, 240 min, 5 h and 6 h postoperatively [Table 5]a and b].


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Nausea and vomiting were lower in Group D when compared to the other two groups, but this difference was found to be statistically insignificant with P = 0.522 and 0.191. Overall five episodes of nausea and four episodes of vomiting were observed in Group N, whereas six episodes of nausea and five episodes of vomiting were observed in Group S. Other side effects such as pruritus and shivering were not observed in any of the study groups.


  Discussion Top


Patients in all the three groups were comparable demographically. They also did not show any significant difference in haemodynamic parameters during the study period with regard to HR, systolic blood pressure, diastolic blood pressure and mean arterial pressures. This shows that the agents (dexmedetomidine and nalbuphine) we have chosen to administer epidurally in their respective doses were safe to use in patients belonging to ASA Grades 1 and 2.[7] Innervation of the knee joint is derived from spinal nerve roots L2 to S3. We chose L1 level which reasonably covers all these nerve roots mentioned above and also covers for the use of tourniquet which is a common practice for TKR surgeries. None of the patients in our study complained of pain either in the surgical site or in the tourniquet area, which shows that our choice of L1 segment for the assessment of block characteristics, such as, time to onset and regression of the block was adequate and thus justified. In other studies, different segments were chosen depending on the requirements for the surgical procedure to be covered.

In our study, the mean time to onset of sensory block (sec) to L1 level was significantly lower in Group D (155.8 ± 67.1 s) compared to Group S (227.5 ± 92.6), whereas time to onset of sensory block (sec) to L1 was comparable between Group D (155.8 ± 67.1) and Group N (184.5 ± 69.7) and also between Group N (184.5 ± 69.7) and Group S (227.5 ± 92.6) [Table 2]. However, in the clinical setting of 2–3 h duration of surgical procedure, difference in the time of onset of sensory block by 2 or 3 min may not be very relevant.

The mean time to onset of sensory block at L1 segment (sec) in our study in Group D was shorter than reported in another study.[8] While we had studied sensory block at L1 segment, the authors[8] had studied block at T10 segment (155.8 Vs 342) using the same dosage and route and this could be reason for differences observed. Type of surgeries studied by them[8] were mostly infraumbilical abdominal surgeries which would require block at least to T10, whereas ours were only lower limb orthopaedic surgeries. The mean time to regression of block below L1 level (min) was shortest in the saline group (170.6 ± 26.4 min) and longest in Group D (319.6 ± 90.1). This suggests that sensory block in the saline group wore off earlier than the other two groups.

The mean time for regression of block below L1 segment (min) in our study in Group D (319.6 ± 90.1 min) was shorter than that reported in another study[8] (367.37) for S1 segment. This difference could be due to the difference in the segments studied (L1 Vs S1).

The mean duration of analgesia (min) was shortest in Group S and longest in Group D, and the difference in the duration of analgesia was statistically significant between the three groups. Further post hoc analysis revealed that this difference was statistically significant between Group S and Group N (P < 0.005); Group S and Group D (P < 0.001); and Group N and Group D ( P < 0.001).

The mean duration of analgesia (min) in Group D in our study (468.5 min) was comparable to that reported in another study[8] (456.87 min) for the same dose and same route. Here, the definition of duration of analgesia was same in both the groups. The analgesic effect of dexmedetomidine is produced by the stimulation of the α2 receptors at spinal cord level. At the dorsal root neuron, α2 agonists inhibit the nociceptive pathway by releasing substance P and by inhibiting the release of norepinephrine, which may have a possible role in analgesia. Even with the evidence of both the supraspinal and peripheral sites of action of dexmedetomidine, the spinal mechanism may be mainly responsible for the analgesic effects.[9],[10]

The mean duration of motor block was shorter in Group S when compared to that of the other two groups. Post hoc analysis showed that this difference was statistically significant between Group S and Group N, Group S and Group D and Group N and Group D.

The mean time to onset of motor block in Group D was much earlier when compared to another study.[8] Further, the mean duration of motor block in Group D was longest in our study when compared to another study.[8] (325 min, 1.5 μg/kg) with the same dose of adjuvant. This difference could be attributed to the usage of hyperbaric bupivacaine by us; in the other study,[8] isobaric levobupivacaine was used.

With regard to adverse effects, 3.3% of patients in Group D, 16.6% in Group N and 20% in Group S developed nausea. None in Group D, 13.3% in Group N and 16.6% in Group S had vomiting. This difference was not statistically significant. This was similar to the observation made in other studies.[8],[11],[12] Similarly, in other studies[13],[14] using epidural nalbuphine, the incidence of side effects was less. With regard to the number of episodes of hypotension, HTN, bradycardia and tachycardia, there was no statistically significant difference among the three groups.

With an average duration of surgery around 3 h, the number of recordings taken at 5 min intervals would be 35–36 on an average in each patient. In each group, thirty patients were studied. Thus, the total number of recordings was approximately 1000. Of these, only 51 episodes of hypotension (51/1000 = 5.1%) and 14 episodes of tachycardia (14/1000 = 1.4%) were observed. These low numbers probably can be ignored when evaluating the safety of dexmedetomidine given epidurally. On the other hand, Group N had a greater number of episodes of HTN (56/1000 = 5.6%) and tachycardia (7/1000 = 0.7%) than the other two groups, but they were not found to be statistically significant. So, these also can be ignored while considering the safety of nalbuphine epidurally.

The mean sedation scores intraoperatively in Group D were observed to be comparatively higher than those of Group N and Group S. This difference was found to be statistically significant at all time intervals (i.e., 30 min, 60 min, 90 min, 120 min, 150 min and at 180 min). This means patients in dexmedetomidine group were well sedated and comfortable throughout the surgery intraoperatively.

The mean sedation scores postoperatively in Group D were found to be higher than those of Group N, which was statistically significant at 30 min, 60 min, 120 min and at 180 min. Group S had lower sedation scores (more awake patients) than Group D, which had statistical significance at 30 min, 60 min, 120 min and 180 min but insignificant at 240 min, 5 h and 6 h. Although the mean sedation scores in Group S were found to be lower than Group N, this was of no statistical significance.

The mean sedation scores in Group D in our study were comparable to that reported in another study.[8] for the same dose, and the sedation scores were also comparable in studies with epidural dexmedetomidine (given as sole analgesic) and the sedation scores were also comparable in studies[11],[12] using epidural demedetomidine (given as sole analgesic) different dosages. The mean sedation scores in Group N in our study were comparable to that reported in a study[14] who used similar dose of nalbuphine (0.2 mg/kg) as an adjuvant to epidural bupivacaine and another study[13] who used epidural nalbuphine (10 mg bolus) solely for post-operative analgesia.

We observed that patients in the Group D were more sedated (i.e., more comfortable) throughout the study period. Sedation is an add-on advantage for regional anaesthesia to bring down the stress associated with the surgery and being wide awake. This advantage was observed well with dexmedetomidine group of patients when compared to other two groups.

The mean VAS scores for pain postoperatively in the Group S were found to be higher than those of Group D, which was statistically significant at 60 min, 120 min, 180 min, 240 min, 300 min, and at 360 min time points postoperatively. In addition, VAS scores in the Group D were comparatively lower than those of Group N, which has some statistical significance at 120 min, 180 min, 240 min, 300 min, and at 360 min postoperatively. VAS scores in Group N were comparatively lower than those of Group S, which was statistically significant at 30 min, 60 min and 120 min. This shows that dexmedetomidine provided statistically significant lower VAS scores than nalbuphine and saline, which explains the longer duration of post-operative analgesia (up to 6 h). Nalbuphine also provided statistically significant lower VAS scores postoperatively that is post-operative analgesia up to 2 h which was still better than that observed in Group S. We observed lower VAS scores postoperatively (i.e., post-operative analgesia) in Group S also, up to less than one hour. This is due to the effect of intrathecal hyperbaric bupivacaine itself.

The mean VAS scores for pain was lower in our study in the dexmedetomidine group and were comparable with that reported in another study[8] for the same dose and same route and also comparable with a study[11] with different doses. Similarly, with regard to epidural nalbuphine, the mean VAS scores were lower and comparable with that of another study.[13] with the same route and similar dose range. These findings suggest that both dexmedetomidine and nalbuphine have modified the VAS scores for pain when given epidurally by providing adequate analgesia intraoperatively as well as extending it to post-operative period.

In our study, the average duration of surgery was ~175 min. Dexmedetomidine provided analgesia postoperatively for an additional period of 293 min, whereas nalbuphine extended analgesia for about 130 min postoperatively. Thus, the very purpose of using an adjuvant to provide better and longer post-operative analgesia and hence delay the use of/and minimise the amount of rescue analgesics had been achieved.

In situations where the epidural catheter becomes non-functional (might have migrated or dislodged from the position) during transfer, etc., even a single dose of epidural adjuvant as has been used in our study can still provide reasonable periods of post-operative analgesia.

Finally, within our knowledge, there were no previous studies which evaluated the effects of epidural nalbuphine on the characteristics of SAB. More studies would be needed in the future to establish the usefulness of nalbuphine as an epidural adjuvant.

Although L1 dermatome level was achieved in all patients in our study and this was adequate for surgeries we studied, this level may not be sufficient for other lower limbs surgeries such as total hip replacement surgery and other infraumbilical surgeries. Most patients expressed satisfaction about the quality of intraoperative anaesthesia and post-operative analgesia. However, we did not analyse these data in our study. More objective tools may be used for this purpose in the future.

We did not study the effect of adjuvants on minimising the quantity of rescue analgesics, which could have provided more objective assessment of analgesic-sparing effect. Both dexmedetomidine and nalbuphine were found to be useful and safe epidural adjuvants when given prior to SAB in the present study design. Dexmedetomidine was found to be a better choice of epidural adjuvant when compared to nalbuphine in terms of earlier onset and longer duration of both sensory and motor block, longer post-operative analgesia and useful intraoperative sedation.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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